Oic Cannulated Screw System, Oic Sliding Hip Screw (SHS) System
FDA 510(k) K113123 · The Orthopaedic Implant Company
510(k) numberK113123
Submission
- Device name
- Oic Cannulated Screw System, Oic Sliding Hip Screw (SHS) System
- Applicant
- The Orthopaedic Implant Company
Greenwood Village, CO, US - Received
- October 21, 2011
- Decision date
- January 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242995 | OIC Small / Mini Fragment Plate SystemHRS · Special | 10/23/2024SE |
| K233531 | OIC FLEX-FIX SystemHTN · Traditional | 02/02/2024SE |
| K223761 | OIC Intramedullary Screw SystemHWC · Traditional | 02/13/2023SE |
| K223118 | OIC Variable Angle Small Fragment Locking Plate SystemHRS · Traditional | 01/21/2023SE |
| K212601 | DRPx Locking Distal Radius Plate SystemHRS · Traditional | 04/05/2022SE |
| K202971 | DRPx Locking Distal Radius Plate SystemHRS · Traditional | 05/06/2021SE |
| K211112 | OIC External Fixation SystemKTT · Special | 05/05/2021SE |
| K183682 | OIC External Fixation SystemKTT · Traditional | 04/08/2019SE |
| K182736 | OIC Suture Anchor SystemMBI · Traditional | 12/28/2018SE |
| K181184 | OIC Intramedullary Nail SystemHSB · Special | 07/27/2018SE |
Questions and answers
When was Oic Cannulated Screw System, Oic Sliding Hip Screw (SHS) System cleared by the FDA?
Oic Cannulated Screw System, Oic Sliding Hip Screw (SHS) System (K113123) received a 510(k) decision of Substantially Equivalent on January 12, 2012, 83 days after the submission was received.
What is the product code of K113123?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.